CLINICAL TRIALS PROFILE FOR TRI-SPRINTEC

All Clinical Trials for TRI-SPRINTEC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01475513 ↗	Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women	Completed	American Heart Association	Phase 4	2011-11-01	Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.
NCT01475513 ↗	Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women	Completed	Virginia Commonwealth University	Phase 4	2011-11-01	Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.
NCT02144246 ↗	Contraceptive Hormones and Women With Cystic Fibrosis	Terminated	Society of Family Planning	Phase 1	2014-05-01	Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations. We hypothesize: 1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit, 1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception, 1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and 1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception. Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls. We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.
NCT02144246 ↗	Contraceptive Hormones and Women With Cystic Fibrosis	Terminated	University of Pennsylvania	Phase 1	2014-05-01	Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations. We hypothesize: 1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit, 1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception, 1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and 1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception. Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls. We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.

Clinical Trial Conditions for TRI-SPRINTEC

Condition Name

Condition Name for TRI-SPRINTEC
Intervention	Trials
Cardiovascular Risk	1
Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception	1
Insulin Sensitivity	1
Perimenopausal Disorder	1

Condition MeSH

Condition MeSH for TRI-SPRINTEC
Intervention	Trials
Fibrosis	1
Cystic Fibrosis	1
Insulin Resistance	1
Hypersensitivity	1

Clinical Trial Locations for TRI-SPRINTEC

Trials by Country

Trials by Country for TRI-SPRINTEC
Location	Trials
United States	2

Trials by US State

Trials by US State for TRI-SPRINTEC
Location	Trials
Pennsylvania	1
Virginia	1

Clinical Trial Progress for TRI-SPRINTEC

Clinical Trial Phase

Clinical Trial Phase for TRI-SPRINTEC
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for TRI-SPRINTEC
Clinical Trial Phase	Trials
Completed	1
Terminated	1

Clinical Trial Sponsors for TRI-SPRINTEC

Sponsor Name

Sponsor Name for TRI-SPRINTEC
Sponsor	Trials
American Heart Association	1
Virginia Commonwealth University	1
Society of Family Planning	1

Sponsor Type

Sponsor Type for TRI-SPRINTEC
Sponsor	Trials
Other	4

Tri-Sprintec: Clinical Trials, Market Analysis, and Projections

Last updated: January 12, 2025

Introduction

Tri-Sprintec, a combination oral contraceptive containing norgestimate and ethinyl estradiol, is widely used for preventing pregnancy and treating moderate acne vulgaris in females. This article delves into the clinical trials, market analysis, and future projections for Tri-Sprintec.

Clinical Trials and Efficacy

Tri-Sprintec has undergone extensive clinical trials to evaluate its efficacy and safety. In four clinical trials, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years, with an overall use-efficacy rate of 1.21 per 100 women-years. These trials involved 4,756 subjects who completed 45,244 cycles, resulting in a total of 42 reported pregnancies[1][2][3].

Pregnancy Prevention

The efficacy of Tri-Sprintec in preventing pregnancy is comparable to other combination oral contraceptives. The drug's active ingredients, norgestimate and ethinyl estradiol, work synergistically to prevent ovulation, thereby reducing the likelihood of pregnancy. Clinical studies have shown that correct and consistent use of Tri-Sprintec can result in lower failure rates, highlighting its reliability as a contraceptive method[1][2].

Acne Treatment

In addition to its contraceptive benefits, Tri-Sprintec is also indicated for the treatment of moderate acne vulgaris in females aged 15 years and older. The hormonal components of the drug help in regulating menstrual cycles and reducing androgen levels, which can contribute to acne. Clinical trials have demonstrated the effectiveness of Tri-Sprintec in improving acne symptoms in patients who have not responded to topical anti-acne medications[1][2][3].

Market Analysis

Current Market

The global market for oral contraceptives, including Tri-Sprintec, is part of the broader pharmaceutical industry. The demand for oral contraceptives remains steady due to their high efficacy and widespread use. Tri-Sprintec, being a well-established brand, holds a significant market share within the combination oral contraceptive segment.

Market Size and Growth

While specific market size data for Tri-Sprintec alone is not readily available, the broader clinical trials market, which includes the development and testing of new drugs like oral contraceptives, provides some context. The global clinical trials market was valued at USD 84.61 billion in 2024 and is projected to grow to USD 146.60 billion by 2033, with a CAGR of 6.07% during the forecast period[4].

Competitive Landscape

Tri-Sprintec competes with other combination oral contraceptives such as Ortho Tri-Cyclen Lo. Both drugs contain the same active ingredients but at different doses, which can influence their effectiveness and side effects profile. Ortho Tri-Cyclen Lo is often prescribed for its lower hormone dosage, while Tri-Sprintec is considered for patients who require more robust menstrual cycle regulation[5].

Market Projections

Future Demand

The demand for oral contraceptives like Tri-Sprintec is expected to remain strong due to their effectiveness and the ongoing need for reliable contraceptive methods. The growing awareness of reproductive health and the increasing prevalence of acne among adolescents and young adults will likely drive the demand for Tri-Sprintec.

Regulatory Environment

The regulatory environment plays a crucial role in the market projection for Tri-Sprintec. As with any pharmaceutical product, regulatory approvals and compliance with safety and efficacy standards are essential. Given that Tri-Sprintec has already been approved by the FDA and has a well-documented history of safety and efficacy, it is likely to continue being a preferred option for both contraception and acne treatment.

Technological Advancements

Advancements in pharmaceutical technology and the development of new formulations could impact the market for Tri-Sprintec. However, given its established position and the lack of significant breakthroughs in oral contraceptive technology, Tri-Sprintec is likely to remain a staple in the market.

Key Takeaways

• Efficacy: Tri-Sprintec has been shown to be highly effective in preventing pregnancy and treating moderate acne vulgaris through extensive clinical trials.
• Market Position: It holds a significant market share within the combination oral contraceptive segment.
• Growth Prospects: The demand for Tri-Sprintec is expected to remain strong due to its reliability and the ongoing need for effective contraceptive and acne treatment options.
• Regulatory Compliance: Continued compliance with regulatory standards will be crucial for its market presence.
• Competitive Landscape: Tri-Sprintec competes with other oral contraceptives like Ortho Tri-Cyclen Lo, each with their own dosage and side effects profile.

FAQs

What are the primary indications for Tri-Sprintec?

Tri-Sprintec is indicated for the prevention of pregnancy in women who elect to use oral contraceptives and for the treatment of moderate acne vulgaris in females aged 15 years and older[1][2][3].

How effective is Tri-Sprintec in preventing pregnancy?

Tri-Sprintec has a use-efficacy pregnancy rate ranging from 0.68 to 1.47 per 100 women-years, with an overall use-efficacy rate of 1.21 per 100 women-years[1].

Can Tri-Sprintec be used for other conditions besides contraception and acne?

No, Tri-Sprintec is specifically indicated for contraception and the treatment of moderate acne vulgaris. It does not protect against HIV infection or other sexually transmitted diseases[1][2][3].

How does Tri-Sprintec compare to other oral contraceptives like Ortho Tri-Cyclen Lo?

Tri-Sprintec and Ortho Tri-Cyclen Lo contain the same active ingredients but at different doses. Tri-Sprintec is often considered for patients who require more robust menstrual cycle regulation, while Ortho Tri-Cyclen Lo is prescribed for its lower hormone dosage[5].

What is the expected market growth for oral contraceptives like Tri-Sprintec?

The broader clinical trials market, which includes the development and testing of new drugs like oral contraceptives, is projected to grow from USD 91.50 billion in 2025 to USD 146.60 billion by 2033, with a CAGR of 6.07%[4].

Sources

1. DailyMed: Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) - DailyMed.
2. Drugs.com: Tri-Sprintec: Package Insert / Prescribing Information - Drugs.com.
3. DailyMed: Tri-Sprintec®(norgestimate and ethinyl estradiol tablets - DailyMed.
4. StraitsResearch: Global Clinical Trials Market Size, Top Share, Trends, Forecast by ...
5. WithPower: Sprintec vs Ortho Tri Cyclen Lo | Power - Clinical Trials.